A Trial Of [S,S]-Reboxetine In Patients With Chronic Painful Diabetic Peripheral Neuropathy. - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00625833

Purpose

This is a trial to investigate the effectiveness and safety of [S,S]-Reboxetine in relieving chronic peripheral pain suffered by patients with diabetes. Some evidence for the effectiveness of [S,S]- Reboxetine in relieving chronic pain has been seen in 3 completed trials.

Condition	Intervention	Phase
Diabetic Neuropathies	Drug: Placebo Drug: [S,S]-Reboxetine	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind Placebo Controlled Trial Of [S,S]-Reboxetine In Patients With Chronic Painful Diabetic Peripheral Neuropathy.

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus Charcot-Marie-Tooth disease hereditary neuropathy with liability to pressure palsies

MedlinePlus related topics: Diabetic Nerve Problems Peripheral Nerve Disorders

Drug Information available for: Reboxetine Reboxetine mesylate

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change from baseline in weekly average pain score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Responder rates (patients with a 30% reduction from baseline in weekly average pain score and patients with a 50% reduction from baseline in weekly average pain score) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from baseline in weekly average sleep interference scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from baseline in the total score and each dimension of the Neuropathic Pain Symptom Inventory [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Modified Brief Pain Inventory-Short Form [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	330
Study Start Date:	December 2007
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo	Drug: Placebo Oral tablet once a day dosing for 10 weeks.
Experimental: 2	Drug: [S,S]-Reboxetine Oral tablet once a day dosing for 10 weeks.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female of any race at least 18 years of age
Diagnosis of painful, distal, symmetrical, sensory-motor polyneuropathy, which is due to diabetes, for at least 1 year
Patients at Visit 1 must have a score ≥40 mm on the Pain Visual Analogue Scale

Exclusion Criteria:

Patients with significant hepatic impairment
Neurological disorders unrelated to diabetic neuropathy that may confuse the assessment of neuropathic pain
Any pain or other condition that may confound assessment or self-evaluation of the pain due to diabetic neuropathy
Amputations other than toes
A current or recent diagnosis (past 6 months) or episode of major depressive disorder and/or uncontrolled depression
History of transient ischemic attack or stroke
Myocardial infarction or unstable angina within the past three months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00625833

Show 56 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier:	NCT00625833 History of Changes
Other Study ID Numbers:	A6061037
Study First Received:	February 14, 2008
Last Updated:	February 16, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Diabetic Neuropathies
Peripheral Nervous System Diseases
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Signs and Symptoms
Poisoning

Substance-Related Disorders
Reboxetine
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 12, 2012